Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis Workshop Summary (2013) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-48
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A strengthened global supply chain for SLDs could save lives by consistently delivering high-quality medicines to more of the people who need them. When SLDs are unavailable to a national TB control programme (NTP)
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In recent years, many countries have been working to scale up MDR TB treatment programs but, as mentioned by several workshop participants, efforts by international organizations and institutions to ensure SLDs are delivered to patients have not kept pace with global MDR TB needs. Challenges facing the global supply chain for SLDs, and the efficient delivery of drugs to patients, include • The overall market for SLDs is relatively small due to limited diag nostic capacity at the country level.
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The workshop summarized in this volume was convened by the Forum to provide a setting for fostering a dialogue on the needs and opportunities for a global supply chain for TB SLDs. The workshop brought together members of the international TB community -- including individuals from U.S.
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• Increased market volumes could attract more manufacturers of QA drugs to the global SLD market and increase competition, reduce prices, and increase availability. • Greater transparency and visibility for manufacturers with regard to demand, QA processes, and financing could improve the SLD supply chain.
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• Regulatory processes, quality standards, and treatment regimens could benefit from harmonization among countries in order to re duce barriers to suppliers entering the SLD market. • Information management systems could improve tracking of opera tional activities of DR TB supply chains.
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The workshop objectives were to consider • what extent and in what ways current mechanisms are or are To not effectively accomplishing what is needed, including consider ation of bottlenecks o The advantages and disadvantages of centralization in the man agement of the global drug supply chain, and potential decen tralized approaches to improve operations of the supply chain o What can be learned from case studies and examples from other diseases (e.g., the Affordable Medicines Facility-malaria [AMFm]
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Initially, GLC was designed as a pilot project mechanism to provide affordable SLDs and to gather data about those projects to inform global policy on the treatment of MDR TB. He also explained the structural and functional evolution of the GLC mechanism, from its initial development as a multi-institutional partnership composed of global stakeholders to its current configuration as an advisory committee to WHO.
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DOTS-Plus pilot projects were designed to collect data from low-income countries with the objective of enabling WHO to change its policy on the treatment of MDR TB in resource-limited settings. A mechanism was needed to make SLDs available at a low cost to those projects.
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As the number of pilot projects began to increase in 2005, the Global Drug Facility (GDF) was brought into the system beginning in 2007 to purchase the increasing volume of SLDs through procurement agents, based on a formal agreement with the GLC Secretariat that year.7 Keshavjee noted that the GLC mechanism had many positive aspects -- most notably the success in encouraging programs to provide a high standard of care to patients, and encouraging countries to view the pilot projects as models for national scale-up.
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SOURCE: Keshavjee, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug Resistant Tuberculosis, adapted from Dr.
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Presentation at IOM workshop on Developing and Figure 1-2 Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis. that the WHO system, including use of GDF to oversee procurement, has not successfully optimized pooled procurement -- it places orders only when funds are made available by countries/programs.
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SLD Supply Chain Structure9 A key characteristic of the supply chain for a predominantly donorfunded drug market, such as the current SLD market MDR TB, is that its two components, the "upstream" segment and the "downstream" segment, are decoupled from one another. This has important implications with regard to issues such as demand, pricing, scale-up, and financing (Figure 1-3)
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The market structure is itself contingent on both 10 This subsection is based on the presentation by Prashant Yadav, Director, Healthcare Research Initiative, William Davidson Institute, University of Michigan. 11 This subsection is based on the presentation by Prashant Yadav, Director, Healthcare Research Initiative, William Davidson Institute, University of Michigan.
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SOURCE: Yadav, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis.
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In other words, the current market context is not conducive to planning ahead; manufacturers often wait for orders to arrive before initiating API production or FPP manufacturing. Yadav suggested that to address the imbalance between order- and 13 This subsection is based on the presentation by Prashant Yadav, Director, Healthcare Research Initiative, William Davidson Institute, University of Michigan.
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Presentation at IOM workshop on Developing and Partially bitmapped Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis. forecast-driven processes in the supply chain, the push-pull boundary could be manipulated such that the interface point is shifted toward expanding the number of forecast-driven steps in the supply chain (Figure 1-5)
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SOURCE: Yadav, 2012. Presentation at IOM workshop on Developing and Figure 1-5 Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis.
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BARRIERS, CHALLENGES, AND NEEDS Cegielski moderated a multi-stakeholder discussion examining the specific barriers, challenges, and needs that prevent the SLD supply chain from operating at optimal efficiency to deliver drugs to MDR TB patients. The first part of this section sets forth an overview of the barriers and challenges that were raised during the individual presentations delivered by Keshavjee; Lucica Ditiu, Executive Secretary, Stop TB Partnership, WHO;
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SOURCE: Mostaghim, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis.
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Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis. panel discussions.
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SOURCE: Keshavjee, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis.
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However, he noted, because much-needed operational changes to support conversion from a pilot project system were never made, the GLC mechanism became structurally incapable of facilitating treatment for the vast majority of MDR TB patients. He noted that GLC and GDF continue to function on a scale more consistent with pilot projects than with the scale of actual patient need.
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Presentation at IOM workshop on Developing and Figure 1-9 Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis. organization, which is a role that it is being called on to play with increasing frequency.
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Keshavjee suggested that a significant barrier imposed by the current organizational structure of the global SLD supply chain is that there is no direct procurement relationship between countries and QA manufacturers. Ditiu remarked that in July 2011, the GLC mechanism was reorganized.
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. Upstream Supply Chain Barriers Individual speakers described several key barriers to efficiency in the upstream SLD supply chain, which was defined by Mostaghim as the segment encompassing the point at which a company decides to produce a drug to the point an order is placed and the drug is tendered.
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26 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB TABLE 1-1 SLD Supply Chain Stakeholders: Responsibilities, Interests, and Barriers Responsibilities Interests Barriers WHO • Help countries • Retain current • Conflict of interest • Set global system structure in reforming the standards due to financial system linked interests and to receipt of "self-perception as substantial overhead central convener" from GDF funds • Control of funding provides leverage/ power over countries Global Fund • Help countries • Improve current • Lacks in-house overcome barriers system structure technical expertise • Use donor funds due to financial on MDR TB appropriately situation • Fears conflict with • Avoid blame for WHO and resulting XDR TB effect on donors Stop TB Partnership • Bring partners • WHO connection • Has operated together to facilitates access essentially as a improve access to to countries subsidiary of WHO TB care • Benefits from rather than a true • Use donor funds size/scale of GDF partnership appropriately operations • Coordinating board not responsive to MDR TB SLD problems Donors • Accountability to • Avoid perception • Political risk of home taxpayers of exerting overt/ backing away from • Ensure good undue influence existing strategy outcomes from on WHO, other they have funded funded projects multilateral bodies Countries • Protect citizens' • Support local • Fear that interests industries complaining would • Deal with and interests lead to loss of epidemics • Avoid hard WHO/donor funds currency • Funding TB not high priority Patients • Access high- • Access to adequate quality treatment SLD regimens • Gain • Highly stigmatized representation in • Unaware of their the system rights • Avoid transmitting disease SOURCE: Keshavjee, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis.
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Restricted market structure -- for example, having only one eligible supplier for a product -- and lack of competition among suppliers in the SLD market are key barriers to improving price and availability. Mostaghim remarked that restricted market structure hinders price improvement in that even if sufficiently deep product volumes were attained, the extent to which that volume is channeled into a single-supplier market structure would curtail improvements in price.
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Projected funding requirements for MDR TB between 2011 and 2015 are estimated at $7.1 billion, around $3.6 billion of which has been approved by the Global Fund in 116 countries. However, the Global Fund's total TB control funding will decline substantially after 2012, despite the increasing prevalence of MDR TB in a number of countries around the world that depend on the Global Fund for financing their TB control programs.22 Hence, if domestic funding is not mobilized to address the MDR TB emerging needs, the Global Fund may be the only funding source for MDR TB management and SLDs in countries such as Armenia, Bangladesh, Bulgaria, Georgia, Kyrgyzstan, Tajikistan, and Uzbekistan.
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SOURCE: Atun, 2012. Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis (edited)
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Yadav stated that the SLD supply chain is limited by an antiquated contracting structure between GDF and manufacturers that is based on public procurement rules from decades ago and that is no longer supported by current empirical or analytical research. He maintained that the contracting practices need to be modernized with more innovative structures, but that such efforts are often met with the response that institutional constraints and the nature of available financing do not allow such innovation.
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Limited availability of SLDs is causally linked with high prices, as multiple participants noted. Regulatory pathways vary widely among countries and have a direct impact on MDR TB patients' access to SLDs.
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Moore delivered a presentation describing the perspective of GDF in its role as a procurement mechanism for GLC-supported programs. Iain Richardson, Senior Director, Global Supply Chain and Logistics, Eli Lilly and Company, and Robert Sebbag, Vice President, Access to Medicines, Sanofi, described challenges and barriers from the perspective of supplying and manufacturing SLDs.
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GDF Procurement Cycle Barriers Moore distinguished between two sections in the GDF procurement cycle -- "pre-order" and "order" (Figure 1-12) -- in describing specific supply chain barriers.
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Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis. GDF's SLD Stockpile To support the order segment of the procurement cycle, GDF established an SLD stockpile with UNITAID funding to expedite emergency orders (delivery within 30 days on average)
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for SLDs, the ordering process remains unpredictable with little to no forecast visibility. With no reliable forecast, in most cases manufacturers will not begin 28 This subsection is based on the presentation by Iain Richardson, Senior Director, Global Supply Chain and Logistics, Eli Lilly and Company.
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29 This subsection is based on the presentation by Iain Richardson, Senior Director, Global Supply Chain and Logistics, Eli Lilly and Company.
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One strategy for systems strengthening that is used in malaria treatment is capacity building to implement best practices at the local supply chain and case management levels to ensure that patients have access to QA drugs. Sebbag noted that this would require both workforce training and active partnership of all players in the SLD supply chain.
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a This box is based on the presentation by Iain Richardson, Senior Director, Global Supply Chain and Logistics, Eli Lilly and Company.
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The South-to-South partnership that GHC established, with ongoing technical and program design input and funding for additional SLDs, ancillary medication, food baskets, social support, laboratory tests, and procedures, was supported by charitable contributions, including a grant from the Eli Lilly MDR-TB Partnership, continued support from the Jolie-Pitt Founda 31 This subsection is based on the presentation by Anne Goldfeld, Professor of Medicine, Harvard Medical School, and Co-founder, GHC.
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The organization committed to pooling procurement of 2,000 treatments from QA sources by negotiating a price drop with manufacturers and buying drugs to guarantee complete treatment.33 MSF currently treats approximately 1,200 patients in 17 countries, using both the GDF procurement mechanism and its own pooled procurement mechanism for certain projects. MSF maintains a stringent QA structure by adhering to the requirements for SLDs deter 32 This subsection is based on the presentation by Myriam Henkens, International Medical Coordinator, MSF.
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A major challenge facing the supply chain for QA SLDs is that despite an increase in the number of QA manufacturers, the prices of QA products have not improved since 2001. Henkens suggested that the fact that Eli Lilly no longer subsidizes capreomycin and cycloserine could account for the increases in price of those drugs, noting that the prices for products that had the same manufacturers in 2001 and 2011 (ethionamide, prothionamide, and PAS)
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Though there are multiple formulators, the current market is overreliant on a single, limited supplier. It was also noted by several workshop participants that individual countries have different approaches for managing MDR TB and the SLD drug supply; country-specific experiences can inform efforts to improve the global supply chain (Box 1-4)
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Andreas Seiter, Senior Health Specialist, Pharmaceuti cals, Health, Nutrition, and Population, World Bank, described India's approach to cofinancing its NTP with the World Bank. South Africa Ndjeka addressed South Africa's approach to the challenges it has faced in treating MDR TB patients and its attempts to shift from pilot projects to a nationally owned program.
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. In such cases the GDF/GLC mechanism is employed using the Pan American Health Organization as a mediator.
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a This box is based on presentations by Joël Keravec, Brazil Country Program Director, Management Sciences for Health (MSH) ; Norbert Ndjeka, MDR TB Director, Department of Health, South Africa; and Andreas Seiter, Senior Health Specialist, Pharmaceuticals, Health, Nutrition, and Population, World Bank.
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• aking steps to accelerate registration, adoption, and uptake could T reduce drug lag in the regulatory process. Key Messagesa • ailure to address the current SLD supply chain issues will lead to F increased drug resistance, morbidity, and mortality.
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• arket fragmentation could be addressed by consolidating and M harmonizing product specifications. Mostaghim offered four strands of market structure adjustments that might help to facilitate patients' access to QA SLDs.
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